CLARENCE, N.Y.--(BUSINESS WIRE)--22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that 22nd Century has launched a new website at www.heraclespharma.com to highlight the Company’s X-22 Very Low Nicotine smoking cessation cigarette in development. With 95% less nicotine than conventional tobacco, X-22 is the first and only smoking cessation product in the form of a combustible cigarette. X-22 smokes, tastes and smells like a regular cigarette but is, based on independent clinical studies, exceptionally effective as a smoking cessation product. With the goal of ultimately commercializing X-22 as a prescription-based pharmaceutical product, 22nd Century’s wholly-owned subsidiary, Heracles Pharmaceuticals, is the only company in the world with an active IND (Investigational New Drug) application with the FDA for a combustible cigarette as a smoking cessation product.
The new Heracles website showcases the extensive clinical research that has incorporated the Company’s proprietary Very Low Nicotine tobacco cigarettes, including 8 completed or ongoing independent Phase II and Phase III clinical studies: http://heraclespharma.com/clinical-trials/. Each of these clinical studies includes a link to the study abstract as posted online, including:
- The 2015 Queen Mary University study that was supported by a grant from the Global Research Awards for Nicotine Dependence (GRAND) funded by Pfizer (PFE),
- The landmark clinical study conducted by Eric C. Donny, Ph.D. et al. – and funded by the FDA – that was published in the October 2015 issue of The New England Journal of Medicine, and
- The ongoing Phase III University of Pittsburg study – also funded by the FDA – that compares an immediate reduction in nicotine to non-addictive levels (using 22nd Century’s proprietary Very Low Nicotine cigarettes with 95% less nicotine) versus a gradual reduction in nicotine to non-addictive levels (using 22nd Century’s proprietary SPECTRUM® government research cigarettes).
The new Heracles website also details 22nd Century’s extensive patent portfolio that protects the Company’s novel technology and allows it to produce what is, by far, the world’s lowest nicotine tobacco http://heraclespharma.com/patent-estate/.
Positioned to disrupt the multi-billion dollar smoking cessation market and to increase the number of smokers willing to try to quit smoking, X-22 is a six-week treatment that utilizes the Company’s proprietary Very Low Nicotine tobacco cigarettes to satisfy a smoker’s craving for cigarettes while separating the act of smoking from the rapid delivery of nicotine. Containing the same proprietary tobacco used in the Company’s proprietary Very Low Nicotine SPECTRUM® government research cigarettes, X-22 significantly reduces cravings with no noticeable withdrawal symptoms. The product does not expose smokers to any new toxicants and has no new side effects. Not surprisingly, the idea of a combustible cigarette that aids in smoking cessation is highly attractive to smokers who wish to quit.
22nd Century is seeking a strategic pharmaceutical partner to fund a final Phase III clinical study in order to complete the Company’s IND application to the FDA for approval of X-22 as a prescription-based smoking cessation aid. As a matter of background, in 2007, Cytos Biotechnology AG received a $38 million up-front payment from Novartis AG (NVS) to conduct a Phase II scientific study on an experimental smoking cessation vaccine. Although the study by Cytos later failed, Novartis had agreed to milestone payments payable to Cytos of up to $600 million. In 2009, and based on results from just one small Phase II study, Nabi Biopharmaceuticals received a $40 million up-front payment from GlaxoSmithKline (GSK) for NicVax, another now failed experimental smoking cessation product. GlaxoSmithKline had agreed to milestone payments of up to $500 million to Nabi. In contrast, 22nd Century seeks a $30 million non-dilutive strategic partner investment based on the compelling results of seven (7) completed Phase II and Phase III studies for a prescription-based product made from the Company’s proprietary Very Low Nicotine tobacco that could prove to be the world’s most effective smoking cessation aid.
“X-22’s message is both very powerful and incredibly simple,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “Very Low Nicotine cigarettes enable smokers to sever the act of smoking from the rapid delivery of nicotine. There are no new behaviors for patients to learn, no pills, no shots… and, perhaps most importantly, X-22 is highly attractive to smokers who wish to quit.” Mr. Sicignano explained further, “Pragmatic medical professionals – including pulmonologists, cardiologists, and radiation oncologists – have written 22nd Century in support of 22nd Century’s extraordinary smoking cessation cigarettes, which is why we are accelerating our efforts to achieve regulatory approval for X-22.”
Mr. Sicignano further noted as follows: “X-22 is a temporary, interim product name and is not approved or endorsed by the U.S. Food and Drug Administration. X-22 is a smoking cessation aid in development. The FDA has not yet (i) evaluated X-22, (ii) approved any combustible cigarettes for use in smoking cessation, or (iii) authorized claims that Very Low Nicotine cigarettes are intended to diagnose, treat, cure, or prevent any disease. 22nd Century is seeking a strategic pharmaceutical partner to fund a final Phase III clinical study in order to complete the Company’s IND application to the FDA for approval of X-22 as a prescription-based smoking cessation aid. In the meantime, if circumstances allow, 22nd Century may introduce Very Low Nicotine smoking cessation cigarettes to markets outside the United States in advance of FDA approval in the United States.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.com for more information.
Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2015, filed on February 18, 2016, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.